U.S. patent number 7,288,063 [Application Number 11/486,776] was granted by the patent office on 2007-10-30 for ivs obturator instrument and procedure.
This patent grant is currently assigned to Sherwood Services AG. Invention is credited to Stuart Morton, Peter Petros.
United States Patent |
7,288,063 |
Petros , et al. |
October 30, 2007 |
IVS obturator instrument and procedure
Abstract
There is disclosed a surgical instrument for inserting material
into the body. The surgical instrument generally includes an outer
tubular member. The instrument has a longitudinal section and an
arcuate section having at least two different radii of curvature.
An inner member is movably positioned within the outer tubular
member and includes structure for engaging a length of material to
draw the material through the outer tubular member and into the
body. Methods of using the surgical instrument to position a length
of tape beneath the urethra to form a support are also
disclosed.
Inventors: |
Petros; Peter (Claremont,
AU), Morton; Stuart (Villepreux, FR) |
Assignee: |
Sherwood Services AG
(Schaffhausen, CH)
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Family
ID: |
30771141 |
Appl.
No.: |
11/486,776 |
Filed: |
July 14, 2006 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20060258897 A1 |
Nov 16, 2006 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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10522450 |
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7094199 |
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PCT/EP03/08067 |
Jul 23, 2003 |
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60397905 |
Jul 23, 2002 |
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Current U.S.
Class: |
600/29;
606/139 |
Current CPC
Class: |
A61B
17/00234 (20130101); A61B 17/06066 (20130101); A61B
17/06109 (20130101); A61B 17/3401 (20130101); A61B
17/06004 (20130101); A61B 2017/00805 (20130101); A61B
2017/0608 (20130101); A61B 2017/061 (20130101); A61B
2017/320044 (20130101); A61F 2/0045 (20130101) |
Current International
Class: |
A61F
2/00 (20060101) |
Field of
Search: |
;600/29-30,37
;128/DIG.25 ;606/72,75,119,139,144,148,185,222,232 ;227/175.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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WOW 02/39890 |
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May 2002 |
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WO |
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WO 03/053252 |
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Jul 2003 |
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WO |
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Other References
PCT International Search Report of International Appln. No.
PCT/EP03/08067 dated Nov. 17, 2003 (6 pages). cited by
other.
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Primary Examiner: Lacyk; John P.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser.
No. 10/522,450 filed on Jan. 20, 2005, now U.S. Pat. No.
7,094,199,which claims the benefit of and priority to International
Application Serial No. PCT/EP2003/008067 filed on Jul. 23, 2003,
which, in turn, claims benefit of and priority to U.S. Provisional
Application Serial No. 60/397,905, filed Jul. 23, 2002 and entitled
IVS OBTURATOR.
Claims
The invention claimed is:
1. A surgical instrument comprising: a first member having a
longitudinal section defining a longitudinal axis; and an arcuate
section extending distally from the longitudinal section, the
arcuate section having a proximal portion, a central portion, and a
distal portion, the proximal portion of the arcuate section curves
away from the longitudinal axis in a first direction and defines a
first radius of curvature, the central portion of the arcuate
section curves towards the longitudinal axis in a second direction
and defines a second radius of curvature, and the distal portion of
the arcuate section curves toward the longitudinal axis in a third
direction and defines a third radius of curvature, wherein each
radius of curvature is different from the other two radii of
curvature.
2. The surgical instrument as recited in claim 1, wherein at least
a portion of the central section extends across the longitudinal
axis in the second direction.
3. The surgical instrument as recited in claim 1, further
comprising a handle at a proximal end the first member.
4. The surgical instrument as recited in claim 3, wherein the
handle has a laterally extending portion.
5. The surgical instrument as recited in claim 4, wherein the
arcuate section defines a first plane and the laterally extending
portion of the handle defines a second plane substantially
perpendicular to the first plane.
6. A method of positioning a length of material in a body
comprising the steps of: (a) providing a surgical instrument
comprising: a first member having a longitudinal section defining a
longitudinal axis, the first member including a hollow outer tube
member; a stylet at least partially movable within the outer
tubular member and engageable with the length of material; and an
arcuate section extending distally from the longitudinal section,
the arcuate section having at least a first portion and a second
portion, the first portion and the second portion having different
radii of curvature; (b) making first and second incisions in the
body; (c) inserting the instrument into the second incision; (d)
passing the instrument through an object in the body, and advancing
the instrument around the body in a substantially arcuate path
towards the first incision such that least a portion of the
instrument is accessible therethrough; (e) engaging the material
with the stylet; and (f) withdrawing the instrument from the
body.
7. The method of claim 6, wherein the object is an obturator
foramen.
8. The method of claim 6, wherein step (d) further comprises
advancing the instrument through the first incision from within the
body such that at least a portion of the instrument extends through
the first incision.
9. The method of claim 6, wherein steps (a) through (f) are
repeated on a contralateral side of the body.
10. The method of claim 6, wherein the stylet is flexible.
11. The method of claim 6, wherein the stylet includes a slot at a
first end for receipt of an end of the material.
12. The method of claim 6, wherein the stylet includes a conical
tip at a second end.
13. The surgical instrument as recited in claim 12, wherein a
diameter of the conical tip is greater than an inner diameter of
the outer tubular member.
14. The surgical instrument as recited in claim 6, wherein the
material comprises a generally flat tape.
15. The surgical instrument as recited in claim 14 wherein at least
one end of the tape is cut at an angle for ease of threading the
tape into the stylet.
16. The surgical instrument of claim 14, wherein the generally flat
tape includes multifilament strands.
17. The surgical instrument of claim 6, wherein the material
includes a generally flat tape and the stylet has a proximal end
adapted to receive an end of the tape.
18. The surgical instrument of claim 17, wherein the stylet is
positioned in the tubular member so that the proximal end of the
stylet is located adjacent a proximal end of the tubular
member.
19. The surgical instrument of claim 6, wherein the stylet has a
distal end that is blunt.
20. The surgical instrument of claim 6, wherein the stylet has a
distal end that is sharp.
21. The surgical instrument of claim 6, wherein a proximal portion
of the arcuate section curves away from the longitudinal axis in a
first direction and defines a first radius of curvature and a
distal portion of the arcuate section curves toward the
longitudinal axis in a second direction and defines a second radius
of curvature.
22. The surgical instrument of claim 21, wherein at least a portion
of the distal portion of the arcuate section extends through the
longitudinal axis of the first member in the second direction.
23. The method of claim 14, wherein the tape includes an absorbable
material.
Description
BACKGROUND
1. Technical Field
The technical field relates to insertion instrumentation for
inserting material into the body and, more particularly, to an
insertion tool and method for inserting a support structure or
material into the body to provide a support to the urethra.
2. Background of Related Art
One problem occurring in women due to the onset of advanced age or
trauma is urinary stress incontinence. Several therapies have been
developed to correct or alleviate this condition, such as, for
example drug therapies and surgical procedures. In some cases it is
necessary to implant a temporary or permanent structure to support
the midline of the urethra to control discharge.
Several surgical procedures have been developed to position a
support against the urethra. Many of these procedures require the
use and installation of bone anchors to affix the ends of the
support to the pubic bone. These procedures are fairly invasive and
require complex instruments to install the bone anchors in the
pubic bone.
One exemplary device and method of inserting, in a minimally
invasive manner, a sling support within the body to support the
urethra is disclosed in certain embodiments of U.S. Pat. No.
5,112,344 to Petros, the entire disclosure of which is hereby
incorporated by reference herein. The Petros reference discloses
the use of an instrument to insert a length of tape through
incisions in the abdomen and the vagina so that the tape supports
the urethra. No bone anchors or other auxiliary structures are used
to anchor the tape. While inserting the tape into the body using
the instrument, the instrument passes through the patient's body on
either side of the bladder. Although this instrument is designed to
safely pass from the incision in the vagina to the incision in the
abdomen, surgeons typically perform a cystoscopy to check the
integrity of the bladder.
It is desirable to have other methods of inserting, in a minimally
invasive manner, support structure or material into the body
without having to pass an instrument through the body on either
side of the bladder.
SUMMARY
In one aspect of the present invention, a surgical instrument for
passing a material into a body in a minimally invasive procedure
comprises a first member having a longitudinal section defining a
longitudinal axis and an arcuate section extending distally from
the longitudinal section; the arcuate section has at least two
different radii of curvature. The shape of the first member
facilitates the passing of the material into the body, in a
minimally invasive procedure. The shape of the first member enables
a material to be placed inside the body in a minimally invasive
procedure so that the material extends through the obturator
foramen.
In certain preferred embodiments, the first member comprises a
hollow outer tubular member. A stylet is at least partially movable
within the outer tubular member and engageable with a material to
pass the material within the body. The hollow outer tubular member
and stylet enable the surgeon to remove the stylet from the outer
tubular member and reinsert the stylet in the opposite position
with respect to the outer tubular member. This structure also
facilitates the placement of the material so that the material
extends from a first side of the pelvis to a second side of the
pelvis.
Preferably, a proximal portion of the arcuate section curves away
from the longitudinal axis in a first direction and defines a first
radius of curvature. A distal portion of the arcuate section curves
toward the longitudinal axis in a second direction and defines a
second radius of curvature. A portion of the distal section
desirably extends across the longitudinal axis in the second
direction.
In certain embodiments, the distal portion of the arcuate section
has a third radius of curvature, different from the second radius
of curvature. The distal portion may have a central section and a
distalmost section. The central section has the second radius and
the distalmost section has the third radius. In certain
embodiments, the second radius is larger than the third radius. In
other embodiments, the second radius is smaller than the third
radius.
The stylet is desirably flexible. In certain preferred embodiments,
the stylet includes a slot at a first end for receipt of an end of
a material. The stylet desirably includes a conical tip at a second
end. A diameter of the conical tip may be greater than an inner
diameter of the outer tubular member.
The outer tubular member desirably has a handle at a proximal end
thereof. In certain preferred embodiments, the handle has a
laterally extending portion. The arcuate section defines a first
plane and the wing defines a second plane substantially
perpendicular to the first plane.
The surgical instrument preferably includes a material and, in
certain preferred embodiments, wherein the material comprises a
generally flat tape. At least one end of the tape may be cut at an
angle for ease of threading the tape into the stylet, in
embodiments in which the stylet comprises a slot for receipt of the
at least one end. The tape desirably comprises a material including
multifilament strands, which may comprise polypropylene strands.
The material may comprise a generally flat tape and the stylet may
have a proximal end adapted to receive an end of the tape. The
material may comprise an absorbable material.
The stylet is desirably positioned in the tubular member so that
the proximal end of the stylet is located adjacent a proximal end
of the tubular member. In certain preferred embodiments, the stylet
has a distal end that is blunt. The distal end may comprise a blunt
conical tip. In other embodiments, the stylet has a distal end that
is sharp.
In a further aspect of the present invention, a surgical instrument
for passing a material into a body in a minimally invasive
procedure, comprises a first member having a longitudinal section
defining a longitudinal axis and an arcuate section extending
distally from the longitudinal section. The arcuate section is
dimensioned and curved whereby when in use and in position in the
body, the arcuate section extends from the skin over the obturator
foramen, through the obturator foramen, to the vaginal wall. The
shape of the first member facilitates the passing of the material
into the body, in a minimally invasive procedure. The shape of the
first member enables a material to be placed inside the body in a
minimally invasive procedure so that the material extends through
the obturator foramen.
BRIEF DESCRIPTION OF THE DRAWINGS
Various embodiments are described herein with reference to the
drawings wherein:
FIG. 1 is a side view of an instrument for use in a surgical
procedure in accordance with an embodiment of the present
invention;
FIG. 2 is a side view of an outer member of the instrument in
accordance with the embodiment of FIG. 1;
FIG. 3 is a bottom view of the outer member of the instrument in
accordance with the embodiment of FIGS. 1 and 2;
FIG. 4 is a side view of a stylet of the instrument in accordance
with the embodiment of FIGS. 1-3;
FIG. 5 is a perspective view of a length of material used with the
instrument in accordance with the embodiment of FIGS. 1-4;
FIG. 6 is a sketch showing the relation of the vagina to the
pelvis;
FIG. 7 is a black and white photograph of the vaginal area during
an initial stage of a surgical procedure in accordance with a
further embodiment of the invention;
FIG. 8 is a black and white photograph similar to FIG. 7, during
initial positioning of the instrument near the obturator foramen of
the pelvis in the procedure in accordance with the embodiment of
FIG. 7;
FIG. 9 is a sketch showing the instrument at the same stage as FIG.
8, in a procedure in accordance with the embodiment of FIGS. 7 and
8;
FIG. 10 is a black and white photograph showing the instrument
turned about 45 degrees relative to the body, at a further stage in
the procedure in accordance with the embodiment of FIGS. 7-9;
FIG. 11 is a sketch showing the instrument at the same stage as
FIG. 10 in the procedure in accordance with the embodiment of FIGS.
7-10;
FIG. 12 is a black and white photograph showing the instrument
rotated about ninety degrees to relative to the body, in a further
stage of the procedure in accordance with the embodiment of FIGS.
7-11;
FIG. 13 is a black and white photograph showing the instrument
rotated 180 degrees to pass through the obturator foramen and with
the tip of the instrument exiting the vaginal incision at a further
stage of the procedure in accordance with the embodiment of FIGS.
7-12;
FIG. 14 is a sketch showing the instrument at the same stage as
FIG. 13 in the procedure in accordance with the embodiment of FIGS.
7-13;
FIG. 15 is a sketch showing the tape threaded into the stylet at a
further stage of the procedure in accordance with the embodiment of
FIGS. 7-14;
FIG. 16 is a black and white photograph showing the tape pulled
through the vagina at a further stage of the procedure in
accordance with the embodiment of FIGS. 7-15;
FIG. 17 is a sketch showing the tape extending from the incision
through the obturator foramen and vaginal incision and out the
vagina at the same stage as FIG. 16 in the procedure in accordance
with the embodiment of FIGS. 7-16;
FIG. 18 is a black and white photograph showing the instrument in a
position to receive a second end of the tape in a further stage of
the procedure in accordance with the embodiment of FIGS. 7-17;
FIG. 19 is a sketch showing the tape passing through each obturator
foramen on both sides of the pelvis and supporting the urethra in a
further stage of the procedure in accordance with the embodiment of
FIGS. 7-18; and
FIG. 20 is a side view of the outer tubular member of an instrument
in accordance with a further embodiment of the invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
A surgical instrument in accordance with an embodiment of the
present invention is shown in FIGS. 1-50. The instrument 10
facilitates insertion of a length of material into the body, for
example, in intravaginal slingplasty procedures. Instrument 10
generally includes an elongate hollow tubular outer member 12 and a
generally flexible stylet 14 configured to pass at least partially
within outer member 12. Outer member 12 includes a longitudinal
section 16 and an arcuate section 18 extending distally from
longitudinal section 16. Outer member 12 is preferably formed from
a biocompatible material such as stainless steel. Outer member
should have a smooth atraumatic surface to prevent trauma to
tissue. A handle 20 is affixed to outer member 13 adjacent a
proximal end 22 thereof.
Referring now to FIG. 2, outer member 12 has a through bore 30
extending from proximal end 22 to a distal end 32 of outer member
12. Through bore 30 is preferably of a uniform diameter, having a
uniform diameter d1. Longitudinal section 16 defines a longitudinal
axis X. Outer member 12 has a shape that generally resembles a
question mark. The arcuate section 18 includes a proximal portion
36, a central portion 38 and a distal portion 40. Proximal portion
36 extends away from longitudinal section 16 and away from the
longitudinal axis X in a first direction Y1. The proximal portion
36 curves away from the longitudinal section 16 and has a radius
R1. The central portion extends from the proximal portion 36 and
extends toward the longitudinal axis X in a second direction Y2,
opposite from the first direction. The central portion curves
toward the longitudinal axis X and has a radius R2. The distal
portion 40 extends from the central portion 38 and extends toward
the longitudinal axis X in the second direction Y2. The distal
portion 40 curves toward the longitudinal and has a radius R3.
In certain preferred embodiments of the invention, the outer member
12 has at least two different radii of curvature. In the embodiment
shown, the central portion 38 has a radius R2 which is different
from the radius R1 of the proximal portion. The outer member may
have additional radii of curvature. For example, certain preferred
embodiments have a distal portion 40 with a radius R3 which is
different than the radius R2 of the central portion 38. Preferably,
in the embodiment shown, R3 is less than R2. This causes distal
portion 40 to curve or recurve back away from a vertical axis Y
relative to longitudinal axis X. Preferably, distal portion 40
forms an angle a relative to vertical axis Y. This is best seen in
FIG. 2. In addition, the distal portion 40 tends to close off the
arcuate section 18 of the outer member 12, as R3 is less than
R2.
While arcuate section 18 generally includes two different radii,
arcuate section 18 may be provided with more than one different
radii, for example R4, R5, etc., or a continuously varying radii.
The shape of the outer member 12 enables the instrument to be
disposed in the body in the intended manner, as discussed
below.
Referring to FIG. 3, handle 20 desirably has a "delta wing" shape,
or a shape with laterally extending portions. The handle 20 has a
tapered front end 42 and wing-like lateral projections 44. This
provides an ergonomic shape to facilitate comfortable and accurate
manipulation of outer member 12. Preferably, handle 20 is formed of
a plastic material and affixed adjacent proximal end 22 of outer
member 12. The handle 20 is preferably oriented on the outer member
12 so as to be disposed in a plane generally perpendicular to the
plane in which the arcuate section 18 is disposed. The orientation
of the handle facilitates the manipulation of the instrument in the
intended manner in the procedure.
The outer member 12 receives the stylet 14. Stylet 14 includes a
conical tip 24 and a proximal end 26 having a hole or slot 28 for
receipt of a length of material therethrough. As noted above,
stylet 14 is provided to draw a length of material through the
body. This can be done directly or through throughbore 30 of the
outer member 12. Referring now to FIG. 4, stylet 14 is formed of a
flexible material and generally has the shape of outer member 12,
including a long section 46 and a curved section 48 extending
distally from the long section 46. Stylet 14 is sufficiently
flexible so as to pass through outer member 12 and has an outer
diameter d2 which is smaller than the diameter of through bore 30,
or the inner diameter of outer member 12. In order to allow the
insertion of instrument 10 while avoiding the separation of stylet
14 from outer member 12, conical tip 24 has an outer diameter d3
which is greater than the diameter of the through bore 30.
Preferably, stylet 14 is formed of a color that is easily visible
against tissue, such as, for example, blue, to assist in locating
the stylet 14 during a surgical procedure. During such surgical
procedure, instruments for visualizing the interior of the body may
be used, such as, for example, equipment for performing a
cystoscopy. The stylet 14 preferably has a color that facilitates
visualization of the stylet 14 during a cystoscopy or using other
techniques or equipment.
As noted above, instrument 10 is designed to facilitate insertion
of a length of material into and through the body, such as, for
example, in an intravaginal slingplasty procedure. Referring
briefly to FIG. 5, a material such as a tape 50 can be used to
support the urethra. Tape 50 has a generally uniform central
portion 52 to support the urethra and tapered ends 54 to facilitate
insertion of tape 50 through slot 28 in the proximal end 26 of
stylet 14. Tapered ends 54 are preferably angle.degree. relative to
the central portion to facilitate insertion into slot 28 of stylet
14. The tape may be made from any mesh, including multifilament or
monofilament mesh materials. The tape is preferably formed from the
material disclosed in certain embodiments of U.S. Pat. No.
5,292,328, the disclosure of which is hereby incorporated by
reference herein. Tape 50 is preferably formed from SurgiPro
(trademark) polypropylene knitted tape available from United States
Surgical, a division of Tyco Healthcare Inc. This material provides
sufficient strength to support the urethra and allow anchoring of
the ends of the tape subcutaneously as described in more detail
hereinbelow. Alternatively, other materials may be used which have
different types of knitted or woven structures, coatings or
different bio-mechanical properties such as absorbable or
semi-absorbable materials. Preferably, the tape comprises a
multifilament mesh that is relatively pliable. Such materials are
less abrasive to tissue than less pliable mesh or mesh comprising
monofilament strands.
The use of the instrument to insert a length of tape for supporting
the urethra will now be described. The procedure generally includes
inserting the instrument through the obturator foramen of the
pelvis to a midline vaginal incision. The stylet can then be used
in order to pass the tape through the tissue. This is done first on
one side and then repeated on the contralateral side. The tape is
positioned beneath the mid-urethra to support the urethra to
achieve continence. During insertion, the tape extends through the
obturator foramen to a point beyond the skin incisions over the
obturator foramen to allow adjustment by traction. After
adjustment, the ends of the tape are sectioned subcutaneously and
all the incisions are closed. Post operatively, fibrous tissue
ingrowth occurs through the tape.
Referring to FIG. 3, there is illustrated a sketch of the vagina
relative to the pubic bone. As shown, the obturator foramen (OF)
exists both sides of the pelvis (PB) adjacent the vagina (VA) and
the urethra (U).
Referring now to FIGS. 7 and 8, a one to two centimeter mid-line
incision is formed in the vaginal wall directly below the mid-point
of the urethra. Using dissection scissors, the vaginal tissue is
dissected laterally towards the obturator foramen on both sides to
a depth of approximately two centimeters. The inferior internal rim
of the obturator foramen is identified by digital examination. A
small one centimeter skin incision is made at the most
inferio-medial part of the obturator foramen. The size of the
incisions made may vary and will depend upon the surgeon.
Referring to FIGS. 7-9, the instrument is held with the outer
member 12 directed obliquely downwardly, at an approximately
45.degree. angle, and toward the midline, with the handle 20
pointing obliquely towards the floor. The conical tip 24 is
inserted into the incision over the obturator foramen. The conical
tip 24 of the instrument is pressed carefully inwardly until the
obturator membrane is pierced. During this movement, the angle of
the instrument remains unchanged.
Referring to FIGS. 10 and 11, once the tip of the instrument has
penetrated the obturator membrane, the instrument handle is turned
towards a 90.degree. angle relative to the body. Using one hand,
the handle is then rotated away from the patient and toward the
midline, allowing the tip of the instrument to pass through the
obturator foramen, around the internal face of the bone and toward
the vaginal incision (See FIG. 12).
Referring to FIGS. 13 and 14, the exit of the tip of the instrument
into the vaginal incision should be guided by a finger of the
surgeon's free hand. The movement of the instrument is continued
until the instrument handle has been rotated a full 180.degree. and
the tip of the instrument has exited the vaginal incision. As best
seen in FIG. 13, the instrument extends from the incision over the
obturator foramen to the vaginal incision.
Referring to FIG. 15, the stylet 14 is then pulled through the
outer member 12 and removed from the outer member 12. The stylet 14
is reinserted into the through bore of the outer member 12 in the
reverse position so that the slot 28 is exposed at the vaginal
extremity of the instrument. A tape 50 is then threaded into the
slot 28 in the stylet 14 and the instrument is extracted to allow
placement of the tape 50 between the vagina and the skin incision
above the obturator foramen (FIG. 17).
Referring to FIGS. 18 and 19, the procedure is then repeated on the
contralateral side in order to position the tape 50 beneath the
mid-urethra, extending laterally towards the obturator foramen on
both sides.
In a further embodiment of the invention, the stylet is not removed
from the outer member 12 and reinserted so that the position of the
stylet 14 is reversed. After the instrument has been passed through
the obturator foramen on the first side, the tape may be inserted
into the slot 28 in the stylet 14 exiting the proximal end of the
outer member 12. The stylet 14 is drawn through the outer tubular
member to draw the tape 50 out through the vaginal incision.
Thereafter, the instrument may be removed, leaving the tape 50
extending from the incision over the obturator foramen, through the
obturator foramen, and out the vaginal incision. The procedure on
the obturator foramen on the second side is the same as discussed
above.
It should be noted that during either procedure, the outer tubular
member of the instrument shields the tape from engagement with the
surrounding body tissues thereby preventing trauma to the tissue.
Once the tape has been positioned beneath the midline of the
urethra through each obturator foramen and out both incisions, the
tape can then be adjusted by traction to be positioned flat beneath
the urethra. The outer tubular member may be inserted into the
urethra during the adjustment to act as a urethral splint. Once
properly adjusted, the free ends of the tape are sectioned
subcutaneously and the vaginal incision, as well as the incisions
over each obturator foramen are closed to complete the procedure.
The approach does not require the use of bone anchors, or
additional anchoring structures. The patient's tissue holds the
ends of the tape in place. Within about twenty-four hours, tissue
ingrowth into the tape begins, which will further secure the
tape.
In further embodiments of the invention, the procedure is carried
out as discussed above in connection with FIGS. 7-19, except that
after the instrument is positioned through the obturator foramen on
the first side, the outer member 12 is removed, leaving the stylet
14 in place in the patient's body. The stylet 14 and tape 50 may be
drawn through the body separately from the outer member 12.
In further embodiments of the invention, the procedure is carried
out as discussed above in connection with FIGS. 7-19, except that
after the instrument is positioned through the obturator foramen on
the first side. The stylet is pulled through the outer member,
drawing the tape from the vaginal incision to the incision over the
obturator foramen.
Referring now to FIG. 20 there is illustrated an alternative
embodiment of an outer tubular member configured to be used with a
stylet such as, for example, stylet 14 described with respect to
obturator instrument 10 above. Outer tubular member 60 generally
includes a longitudinal section 62 defining a longitudinal axis X
and an arcuate section 64 extending distally from longitudinal
section 62 in a manner similar to that described hereinabove with
respect to outer tubular member 12. Outer tubular member 60
desirably further includes a recess 66 formed adjacent a proximal
end 68 of outer tubular member 60 to facilitate placement of a
handle member.
In a preferred embodiment of outer tubular member 60, R1 is 17.5
units and R2 and R3 are 23 and 25 units respectively. Angle A is
approximately 33.degree..
In the embodiment discussed above in connection with FIGS. 1-5,
the
inner stylet desirably comprises a blunt tip. The blunt tip is
sufficient for bluntly tunneling through tissue and for penetrating
the obturator membrane. In other embodiments, the tubular outer
member, the inner stylet, or both, may have an incisive tip.
In the embodiment discussed above in connection with FIGS. 1-5, the
stylet comprises a slot for receiving a length of tape. In other
embodiments, the instrument is as discussed above in connection
with FIGS. 1-5, except that the stylet comprises a feature for
attaching the tape to the stylet, such as a snap-together part that
engages a corresponding part on the tape. In other embodiments, the
instrument is as discussed above in connection with FIGS. 1-5,
except that the outer tubular member comprises a slot for receiving
a length of tape. In further embodiments, the outer tubular member
comprises a feature for attaching the tape to the stylet, such as a
snap-together part that engages a corresponding part on the
tape.
In further embodiments, the instrument is as discussed above in
connection with FIGS. 1-5, except that the tape has an enlarged
portion disposed between the ends of the tape. In further
embodiments, the tape has other shapes, such as rectangular,
circular, elliptical, arcuate, etc.
The instrument may comprise a tubular outer member and inner
stylet, as discussed above, or a unitary introducer element. The
tubular outer member and inner stylet has the advantage that the
position of the stylet can be reversed with respect to the tubular
member. In other words, the slot, or other feature for engaging the
tape, may be positioned at the proximal end of the outer member or
the distal end of the outer member. In addition, the tubular outer
member shields the tape from the body, as the tape is pulled
through the outer member. In embodiments employing a unitary
introducer element, a sheath for enclosing the tape as the tape is
passed through the body may be desired.
Although the invention herein has been described with reference to
particular embodiments, it is to be understood that these
embodiments are merely illustrative of the principles and
applications of the present invention. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the invention as
defined by the appended claims. For example, embodiments of the
present invention encompass a unitary introducer element, as
opposed to the outer tubular member and inner stylet discussed
above. In certain embodiments, the surgical instrument for passing
a material into a body in a minimally invasive procedure comprises
an introducer element having a longitudinal section defining a
longitudinal axis and an arcuate section extending distally from
the longitudinal section, the arcuate section having at least two
different radii of curvature. The material desirably comprises a
tape of mesh material. The proximal end of the introducer element
is desirably adapted to receive an end of the tape. In other
embodiments, a distal end of the introducer element is desirably
adapted to receive an end of the tape.
In certain embodiments, the surgical instrument for passing a
material into a body in a minimally invasive procedure comprises an
introducer element having a longitudinal section defining a
longitudinal axis and an arcuate section extending distally from
the longitudinal section, the arcuate section being dimensioned and
curved whereby when in use and in position in the body, the arcuate
section extends from the skin over the obturator foramen, through
the obturator foramen, to the vaginal wall. The material desirably
comprises a tape of mesh material. The proximal end of the
introducer element is desirably adapted to receive an end of the
tape. In other embodiments, a distal end of the introducer element
is desirably adapted to receive an end of the tape.
In certain embodiments, the surgical instrument for passing a
material into a body in a minimally invasive procedure comprises an
introducer element having a longitudinal section defining a
longitudinal axis and an arcuate section extending distally from
the longitudinal section, the arcuate section having a proximal
portion which curves away from the longitudinal axis in a first
direction, the arcuate section having a distal portion which curves
toward the longitudinal axis in a second direction. The material
desirably comprises a tape of mesh material. The proximal end of
the introducer element is desirably adapted to receive an end of
the tape. In other embodiments, a distal end of the introducer
element is desirably adapted to receive an end of the tape.
In a further aspect of the present invention, a surgical instrument
for passing a material into a body in a minimally invasive
procedure, comprises a first member having a longitudinal section
defining a longitudinal axis and an arcuate section extending
distally from the longitudinal section. The arcuate section is
dimensioned and curved whereby when in use and in position in the
body, the arcuate section extends from the skin over the obturator
foramen, through the obturator foramen, to the vaginal wall. The
shape of the first member facilitates the passing of the material
into the body, in a minimally invasive procedure. The shape of the
first member enables a material to be placed inside the body in a
minimally invasive procedure so that the material extends through
the obturator foramen.
In certain preferred embodiments, the first member comprises a
hollow outer tubular member. A stylet is at least partially movable
within the outer tubular member and engageable with a material to
pass the material within the body. The hollow outer tubular member
and stylet enable the surgeon to remove the stylet from the outer
tubular member and reinsert the stylet in the opposite position
with respect to the outer tubular member. This structure also
facilitates the placement of the material so that the material
extends from a first side of the pelvis to a second side of the
pelvis.
Preferably, a proximal portion of the arcuate section curves away
from the longitudinal axis in a first direction and defines a first
radius of curvature. A distal portion of the arcuate section curves
toward the longitudinal axis in a second direction and defines a
second radius of curvature. A portion of the distal section
desirably extends across the longitudinal axis in the second
direction.
In certain embodiments, the distal portion of the arcuate section
has a third radius of curvature, different from the second radius
of curvature. The distal portion may have a central section and a
distalmost section. The central section has the second radius and
the distalmost section has the third radius. In certain
embodiments, the second radius is larger than the third radius. In
other embodiments, the second radius is smaller than the third
radius.
The stylet is desirably flexible. In certain preferred embodiments,
the stylet includes a slot at a first end for receipt of an end of
a material. The stylet desirably includes a conical tip at a second
end. A diameter of the conical tip may be greater than an inner
diameter of the outer tubular member.
The outer tubular member desirably has a handle at a proximal end
thereof. In certain preferred embodiments, the handle has a
laterally extending portion. The arcuate section defines a first
plane and the wing defines a second plane substantially
perpendicular to the first plane.
The surgical instrument preferably includes a material and, in
certain preferred embodiments, wherein the material comprises a
generally flat tape. At least one end of the tape may be cut at an
angle for ease of threading the tape into the stylet, in
embodiments in which the stylet comprises a slot for receipt of the
at least one end. The tape desirably comprises a material including
multifilament strands, which may comprise polypropylene strands.
The material may comprise a generally flat tape and the stylet may
have a proximal end adapted to receive an end of the tape. The
material may comprise an absorbable material.
The stylet is desirably positioned in the tubular member so that
the proximal end of the stylet is located adjacent a proximal end
of the tubular member. In certain preferred embodiments, the stylet
has a distal end that is blunt. The distal end may comprise a blunt
conical tip. In other embodiments, the stylet has a distal end that
is sharp.
In yet another aspect of the present invention, a surgical
instrument for passing a material into a body comprises a tubular
member having a longitudinal section defining a longitudinal axis
and an arcuate section extending distally from the longitudinal
section. The arcuate portion has a proximal portion which curves
away from the longitudinal axis in a first direction and a distal
portion which curves toward the longitudinal axis in a second
direction. The shape of the first member facilitates the passing of
the material into the body, in a minimally invasive procedure. The
shape of the first member enables a material to be placed inside
the body in a minimally invasive procedure so that the material
extends through the obturator foramen.
A stylet is at least partially movable within the outer tubular
member and engageable with a material to pass the material within
the body. The hollow outer tubular member and stylet enable the
surgeon to remove the stylet from the outer tubular member and
reinsert the stylet in the opposite position with respect to the
outer tubular member. This structure also facilitates the placement
of the material so that the material extends from a first side of
the pelvis to a second side of the pelvis.
Preferably, a proximal portion of the arcuate section curves away
from the longitudinal axis in a first direction and defines a first
radius of curvature. A distal portion of the arcuate section curves
toward the longitudinal axis in a second direction and defines a
second radius of curvature. A portion of the distal section
desirably extends across the longitudinal axis in the second
direction. Desirably, the distal portion of the arcuate section has
at least two different radii.
In certain embodiments, the distal portion of the arcuate section
has a third radius of curvature, different from the second radius
of curvature. The distal portion may have a central section and a
distalmost section. The central section has the second radius and
the distalmost section has the third radius. In certain
embodiments, the second radius is larger than the third radius. In
other embodiments, the second radius is smaller than the third
radius.
The stylet is desirably flexible. In certain preferred embodiments,
the stylet includes a slot at a first end for receipt of an end of
a material. The stylet desirably includes a conical tip at a second
end. A diameter of the conical tip may be greater than an inner
diameter of the outer tubular member.
The outer tubular member desirably has a handle at a proximal end
thereof. In certain preferred embodiments, the handle has a
laterally extending portion. The arcuate section defines a first
plane and the wing defines a second plane substantially
perpendicular to the first plane.
The surgical instrument preferably includes a material and, in
certain preferred embodiments, wherein the material comprises a
generally flat tape. At least one end of the tape may be cut at an
angle for ease of threading the tape into the stylet, in
embodiments in which the stylet comprises a slot for receipt of the
at least one end. The tape desirably comprises a material including
multifilament strands, which may comprise polypropylene strands.
The material may comprise a generally flat tape and the stylet may
have a proximal end adapted to receive an end of the tape. The
material may comprise an absorbable material.
The stylet is desirably positioned in the tubular member so that
the proximal end of the stylet is located adjacent a proximal end
of the tubular member. In certain preferred embodiments, the stylet
has a distal end that is blunt. The distal end may comprise a blunt
conical tip. In other embodiments, the stylet has a distal end that
is sharp.
In a further aspect of the present invention, a method of
suspending a portion of the urethra with a length of material
comprises the steps of providing a surgical instrument having an
outer tubular member including a longitudinal proximal end and a
curved distal end and a stylet movable within the tubular member
and configured to hold an end of the length of material. The method
includes positioning the stylet within the tubular member. A
vaginal incision and an incision located over the obturator foramen
are made. The curved distal end of the surgical instrument is
passed through the incision over the obturator foramen. The method
includes manipulating the surgical instrument such that the curved
distal end passes through the obturator foramen and out the vaginal
incision. A proximal end of the stylet is engaged with a first end
of the length of material, and the stylet is drawn through the
tubular member to draw a portion of the length of material from the
incision over the obturator foramen and through the vaginal
incision.
The outer tubular member may be withdrawn through the incision over
the obturator foramen leaving the length of material extending
through the obturator foramen and out the vaginal incision. The
step of passing the curved distal end of the surgical instrument
through the incision over the obturator foramen desirably includes
rotating the surgical instrument approximately 30 degrees upward in
relation to the body. The surgical instrument is desirably elevated
to position the curved distal end through the obturator foramen.
The surgical instrument is rotated to pass the curved distal end
through the obturator foramen and out the vaginal incision.
In a further aspect of the present invention, a method of
suspending a portion of the urethra comprises the steps of passing
a curved distal end of a surgical instrument through the body so
that the instrument extends between a vaginal incision and a skin
incision located over the obturator foramen. The surgical
instrument has an outer tubular member including a longitudinal
proximal end and a curved distal end and a stylet movable within
the outer tubular member. The stylet is drawn through the body to
draw the length of material through the body, extending between the
vaginal incision and the incision over the obturator foramen.
The step of passing the curved distal end of the instrument
desirably includes inserting the curved distal end of the
instrument into the incision over the obturator foramen and moving
the curved distal end through the obturator foramen, out the
vaginal incision. The step of passing the curved distal end of the
instrument desirably includes inserting the curved distal end into
the vaginal incision. During the step of passing the curved distal
end of the instrument, the stylet is desirably disposed within the
outer tubular member.
The method may include, after the step of passing, withdrawing the
stylet from the outer tubular member. The stylet may be reinserted
in the outer tubular member so that an end of the stylet adapted to
receive the material is disposed at the vaginal incision. The
material is desirably disposed so that the material is received by
the end of the stylet.
The step of drawing may include withdrawing the stylet through the
outer tubular member, thereby drawing the material through the
outer tubular member, and removing the outer tubular member through
the body. The step of drawing may include withdrawing the stylet
and outer tubular member from the body, thereby drawing the
material through the body.
The step of passing desirably comprises passing the instrument
through the body on a first side of the pelvis and further
desirably comprises passing the instrument through the body on a
second side of the pelvis.
The material desirably comprises a tape having a first end and a
second end and the step of drawing desirably includes drawing a
first end of the tape through the body and drawing a second end of
the tape through the body.
* * * * *